BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PANTRIDGE MK III DEFIBRILLATOR/MONITOR

    K Number: K780416 · Decision Apr 21, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    23
    Review Days
    38

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    Basic Information

    Device Name
    PANTRIDGE MK III DEFIBRILLATOR/MONITOR
    K Number
    K780416
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ipco Corp.
    Date Received
    March 14, 1978
    Decision Date
    April 21, 1978
    Product Code
    LDD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

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